A Study of the Safety and Activity of Experimental ABBV-744 For Metastatic Prostate Cancer and Acute Myeloid Leukemia

Enter your info and the study team will contact you soon!
Your data is securely stored and only shared with the research team
Logo Image
"Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!"
Age: 18 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: acute myeloid leukemia, AML, leukemia, Metastatic Castrate-Resistant Prostate Cancer, prostate cancer
Type: Drug study, Phase 1
Target:
8 Participants
Investigator:
Description
This is a research study for an experimental drug called ABBV-744. It will be studied in patients with relapsed/refractory acute myeloid leukemia (AML). An investigational drug is one that has not been approved by the FDA.

The purpose of this study is:
- to see if ABBV-744 is safe
- to determine a safe dose of ABBV-744
- to see how much ABBV-744 is in your blood at various times (these tests are called "pharmacokinetics" or "PK")
- to determine if treatment with ABBV-744 leads to tumor shrinkage.

This study is for patients with relapsed (cancer has returned) or refractory (cancer is not responding to treatment) acute myeloid leukemia.

The study sponsor (AbbVie) requests that we site collect tissue samples (including blood samples and tumor biopsies) for research purposes. This can help researchers (including your doctor and AbbVie) to better understand why certain people respond differently to ABBV-744.

This is called “biomarker” research. ABBV-744 is a drug called a Bromodomain and extra-terminal (BET) inhibitor. BET proteins read DNA modifications that determine which genes are active. ABBV-744 interferes with this reading. If reading such DNA modifications are needed for the survival and growth of cells in a tumor, the tumor may be slowed or stopped.
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

Inclusion criteria:

  • Participant must have metastatic CRPC or AML not amenable to curative therapy, refractory to standard of care therapy or for which standard of care therapy does not exist. Participants with AML who are candidates for stem cell transplantation must have been offered this therapeutic option. Must meet additional criteria specific for each diagnosis, metastatic CRPC and relapsing/remitting AML, as described in the protocol.
  • Must consent to provide biomarker analyses as described in the protocol.
  • Must have an Eastern Cooperative Oncology Group (ECOG) Performance status of:
  • Dose Escalation (Segment 1): 0 - 1
  • Dose Expansion (Segment 2): 0 - 2
  • Dose Escalation: Must have a serum albumin during Screening of >= 3.2 g/dL.
  • Participant has adequate bone marrow, renal and hepatic function.

Exclusion criteria:

  • Participant has untreated brain or meningeal metastases.
  • Participant has received anti-cancer traditional medicine or anti-cancer herbal remedies within 14 days prior to ABBV-744 dosing. Saw palmetto is considered anti-cancer herbal remedy. Participant with CRPC who has received anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, biologic or any investigational therapy within a period of 21 days prior to Study Day 1. Participant with AML has received anti-cancer therapy within a period of 14 days or 5 half-lives (whichever is longer; except for immunotherapy where a period of 21 days will be acceptable) prior to Study Day 1. Except for hydroxyurea which will be allowed during screening and treatment for controlling leukocytosis for AML subjects.
  • Participant has unresolved toxicities from most recent prior anti-cancer therapy, defined as any Common Terminology Criteria for Adverse Events (CTCAE v 4.03) grade 2 or higher clinically significant toxicity (excluding alopecia).
  • Participant has received the following within 7 days prior to the first dose of study drug: corticosteroid therapy, CYP3A inhibitors, CYP3A inducers.
  • Participant consumed grapefruit or grapefruit products within 3 days prior to the first dose of study drug.
  • Participant had major surgery within 28 days prior to Study Day 1.
  • Participant is unable to swallow or absorb oral tablets.
  • Participant has known infection with hepatitis B or hepatitis C.
  • Participant has active peptic ulcer disease or other hemorrhagic esophagitis/gastritis, enteritis, colitis.
  • Participant has symptoms of gross hematuria or gross hemoptysis
  • Has electrocardiogram with a QT interval corrected for heart rate using Fridericia's formula (QTcF) > 470 msec or ECG with second degree type 2 or third degree atrioventricular block.
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
Schedule
Study duration and period
The study will last about 6-9 months and include about 20 study visits to the research center. Depending on how you respond to this drug, the time you spend in the study could be higher or lower.
Recruitment period
From Aug. 1, 2018
Location
UC Davis Comprehensive Cancer Center
4501 X Street
Sacramento, CA 95817
Research Topic
Conditions:
  • Prostate Cancer
  • Acute Myeloid Leukemia (AML)